Comparing monitoring strategies for patients with new left bundle branch block after heart valve surgery
Official title: Comparison of a Clinical Monitoring Strategy Versus Electrophysiology-guided Algorithmic Approach in Patients With a New Left Bundle Branch Block After Transcatheter Aortic Valve Implantation (TAVI) a Bayesian Randomized Trial (COME-TAVI)
Run by Montreal Heart Institute · NCT03303612 · Data updated 2026-11-12
This study is testing if a new monitoring method can help people who develop a heart condition after valve surgery feel better and avoid serious problems like fainting or hospitalization.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | Montreal Heart Institute Academic / other |
| Locations | 10 sites (Edmonton, Alberta and 9 other locations) |
| Status | Recruiting |
| Started | October 15, 2017 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | October 14, 2026 |
| Trial ID | NCT03303612 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who develop persistent new-onset LBBB following TAVI and do not have a history of pacemaker implantation.
✕Probably not a fit
Patients with prior pacemaker or implantable cardioverter-defibrillator, or those with pre-existing bundle branch blocks will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates whether an electrophysiology-guided algorithmic approach is more effective than standard clinical follow-up in managing patients who develop new left bundle branch block (LBBB) after transcatheter aortic valve implantation (TAVI). Patients aged 18 and older without prior pacemakers will be randomized into two groups: one receiving the electrophysiology-based approach and the other undergoing standard monitoring. The primary goal is to reduce the incidence of syncope, hospitalization, and death in this patient population. Participants will be monitored for 30 days post-implantation to assess outcomes.
Why it matters
Potential benefit: If successful, this approach could lead to improved management and outcomes for patients experiencing new LBBB after TAVI.
How similar studies have gone: While the specific approach may be novel, similar studies have shown promise in improving outcomes for patients with cardiac conduction issues.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * Informed consent to participate * Persistent new-onset LBBB after TAVI implantation (i.e. present at day 2) Exclusion Criteria: * Prior pacemaker or implantable cardioverter-defibrillator * Pre-existing right bundle branch block (RBBB) or LBBB (i.e., prior to TAVI) * Class I or IIA indication for PPM implantation according to management guidelines
Where it's running
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Mazankowski Alberta Heart Institute
Edmonton, Alberta, Canada Recruiting -
QEII Health Sciences Center
Halifax, Nova Scotia, Canada Recruiting -
Hamilton Health Sciences Corporation
Hamilton, Ontario, Canada Recruiting -
London Health Sciences Center (LHSC)
London, Ontario, Canada Recruiting -
University of Ottawa Heart Institute (UOHI)
Ottawa, Ontario, Canada Recruiting -
Montreal Heart Institute
Montreal, Quebec, Canada Recruiting
Show 4 more locations
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CIUSSS du Nord de l'Île de Mtl
Montreal, Quebec, Canada Recruiting -
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, Canada Recruiting -
New Brunswick Heart Center
Saint John, New Brunswick, Canada Not yet recruiting -
Centre Hospitalier Universitaire de Nantes
Nantes, Cedex 01, France Not yet recruiting
Study contacts
- Principal investigator: Léna Rivard, MD, MSC — Montreal Heart Institute
- Study coordinator: Léna Rivard, MD, MSc
- Email: lena.rivard@umontreal.ca
- Phone: 514-376-3330
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Transcatheter Aortic Valve Replacement Registry for Outcomes and Quality Monitoring
This registry collects information from hospitals about patients undergoing TAVR to see how care and outcomes compare to guidelines and nationwide data.
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Left bundle branch area pacing with multimodal guidance vs. conventional pacing for heart failure with complete left bundle branch block
A multicenter trial tests whether using multimodal data to guide left bundle branch area pacing helps people with heart failure and complete left bundle branch block, compared with traditional biventricular pacing.
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Vericiguat to slow calcific aortic valve narrowing
This trial tests whether vericiguat can slow the progression of mild-to-moderate calcific aortic valve stenosis compared with placebo.
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CHATEAU Registry: Real-world outcomes after TAVR
This registry collects real-world data from adults who had TAVR between 2021 and 2025 to see how they do over time and how valve performance holds up.
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Impact of TAVR on kidney function in people with aortic valve disease
This registry tests how trans-catheter aortic valve implantation affects kidney function and the risk of kidney injury in adults with aortic stenosis.
-
ML-based diagnosis of blocked arteries in patients with a left bundle branch block
Doctors are testing a machine learning tool that uses digital ECGs to see if a blocked coronary artery is present in patients with a left bundle branch block.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.